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Quality Engineer - FDA Regulated Products

Bay Shore, NY, US • Posted 1 day ago • Updated 1 hour ago

Full Time

On-site

Compensation information provided in the description

Fitment

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Job Details

Skills

ISO 9000
Risk Management
Corrective And Preventive Action
Quality Assurance
Communication
Problem Solving
Conflict Resolution
Product Development
Functional Requirements
Risk Assessment
Root Cause Analysis
Surveillance
Documentation
Auditing
Continuous Improvement
Quality Management
Supply Chain Management
Six Sigma
Medical Devices
Manufacturing
Management

Summary

Quality Engineer, FDA Regulated Product Development

Location: Bay Shore, NY (On-site)
Job Type: Full-time, Direct Hire
Pay: $90,000 to $110,000 per year

Build quality into products from the first design phase through manufacturing and the field, with real ownership across the full product lifecycle.

Must-Haves

Bachelor\'s degree in Engineering, Quality Management, or a related field
Proven experience as a Quality Engineer in manufacturing or product development
Knowledge of ISO and FDA regulatory requirements
Strong skills in risk management, root cause analysis, and CAPA
Solid understanding of quality assurance methods and product development processes
Excellent communication and problem-solving skills

What You\'ll Do

Support new product development by defining and enforcing quality requirements from design onward
Lead risk assessments, design verification, and design validation
Provide sustaining manufacturing quality support and resolve production quality issues
Lead root cause analysis and drive corrective and preventive actions
Support post-market surveillance and partner with field teams on product performance
Maintain documentation for regulatory submissions and audits
Use data and metrics to drive continuous improvement in quality systems
Partner with engineering, manufacturing, and supply chain to build a culture of quality

Nice-to-Haves

ASQ Certified Quality Engineer (CQE)
Six Sigma certification
Medical device or FDA-regulated manufacturing experience

Compensation and Benefits

$90,000 to $110,000 per year
Direct hire opportunity

About the Company
Our client is an established Long Island manufacturer developing and producing products in a regulated industry.

To apply, submit your resume for consideration.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: appfeed
Position Id: 29356_978079664899533
Posted 1 day ago

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